Sentinel Node Detection in Cervical Cancer

Launched by REGION SKANE · Sep 20, 2018

Keywords

ClinConnect Summary

Consecutive women with stage 1a2-2a1 cervical cancer scheduled for surgery will be approached for eligibility by defined criteria.

Sentinel nodes will be detected by a combined use of Indocyanine green and Tc99 radiocolloid ( first 75 patients) and for the continuation with either the combined use or the best performing of those tracers.

Technical success rates, adverse events (related study intervention and overall) sensitivity and negative predictive values will be estimated.

An interim analyse will be performed after 34 node positive patients based on the Fleming two stage analyse. Th...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Women of age 18 years and older at the time of informed consent.
• • Women with a pathologically proven cervical carcinoma of any histologic subtype, clinically stage 1a2- 2a1 planned for primary surgery
• • Absence of any exclusion criteria
• Exclusion Criteria:
• • Non consenting patients
• • Ongoing pregnancy
• • Inability to understand written and/or oral study information
• • Who performance status III or more
• • Previous lower limb lymphedema
• • Surgical contraindication to a laparoscopic approach or lymphadenectomy at surgeons discretion.
• • Anesthesiologic contraindication to a laparoscopic approach at the anesthetist's discretion
• • Locally advanced disease or intraabdominal/distant metastases at preoperative CT, MRI or ultrasonography
• • Radiologically suspect pelvic nodal metastatic disease according to the RECIST criteria (\>= 1 node with \>=16 mm short axis diameter)
• • Allergy to Iodine
• • Patients with a known liver disease
• • Patients with a significant bleeding disorder or mandatory antithrombotic treatment.